(Not applicable)
1. Field of the Invention
In particular, but not exclusively, the present invention is directed to an apparatus and process in which the following physical treatments can be applied to tissue or other work surfaces in conjunction with a clinical procedure: suction and blowing; suction, irrigation and blowing; agent application and blowing; suction, agent application and blowing; suction, sealant agent application, blowing and irrigation, to effect hemostasis, close wounds or achieve other therapeutic results. Some, or all of such combinations of treatments may be novel.
2. Description of the Related Art Including Information Disclosed under 37 CFR 1.97 and 37 CFR 1.98
Use of tissue sealants and other biological materials is an important emerging surgical technique, well adapted for the operating room or field environments such as the doctor""s office or mobile medical units. In addition, the application of such sealants while performing or as necessary to perform minimimally evasive surgery reduces or eliminated the traditional problems associated with more evasive types of procedures. Preferred sealants include fibrin sealants which are formed from blood plasma components and comprise, on the one hand, a first component containing fibrinogen and Factor XIII and on the other hand a second component which usually includes thrombin, and calcium ions.
The fibrinogen is capable of a polymerizing and being cross-linked to form a solid fibrin clot when the components are mixed. The necessary additional factors to simulate relevant portions of the natural blood coagulation cascade are suitably distributed between the fibrinogen and thrombin components.
High levels of protection against transmission of infections or induction of immunological reactions can be assured by using an autologous or single-donor source for both components. Such sealants are highly effective, are biologically degraded without residue and may promote wound healing.
Depending upon the potency of the particular formulations employed, coagulation of the sealant may take place very rapidly, yielding a gel within perhaps 10 or 20 seconds after mixing of the two components.
Antanavich et al. U.S. Pat. No. 5,585,007, whose disclosure and references are hereby incorporated herein by reference thereto, provides an extensive discussion of the literature relating to fibrinogen sealant preparation (column 1, line 20 to column 4, line 62) and applicators column 4 line 62 to column 5, line 14), as well as a bibliography, (columns 6-10) and is a helpful guide to the teachings of prior workers in the field.
To foster and complement the emerging use of tissue sealants in a surgical environment there is a growing need for apparatuses and methods to assist the deployment of such materials, for example, by preparing, conditioning or manipulating the work surface or its surroundings.
As long as doctors have been performing surgery or medical procedures, inventions have been made and implemented to promote less intrusive procedures, to reduce the time required to perform procedures, and to provide enhanced patient treatments and outcomes.
It is common practice provide a surgeon at the point of care with any one or more of a number of fluids to be dispensed in or to a work surface, such as human or veterinary patient tissues, or the environment of those tissues. Some examples of such fluids are suction to remove unwanted materials and manipulate tissue and irrigation fluids such as saline.
Tofflemire U.S. Pat. No. 2,812,765 discloses a handheld applicator for selectively dispensing irrigation fluid, air, or other fluids, or suction. Tofflemire provides a frusto-conical valve B rotatable by a knob 11 to selectively connect sources of irrigation fluid I, air A or suction S with a tubular tip D. Tofflemire lacks point-of-use flow controls for any of the dispensed fluids and cannot be used for sealant dispensing, as sealant would jam valve B. Furthermore, tip D is excessively elongated, being longer than the body comprised by transverse bar 38 and sheath 43. Such elongation is unwieldy and unsuitable for dispensing a mixed sealant which might set up in the dispensing cannula, tip D.
Epstein U.S. Pat. No. 5,266,877, whose disclosure is also incorporated herein by reference, teaches one form of combination hand-held applicator which can dispense a mixed, two-component tissue sealant, discharged from on-board reservoirs, to close wounds and effect hemostasis and which is also furnished with suction means for applying suction from a cannula alongside a sealant dispensing cannula, to treat a work surface. The suction means is connectable with an external vacuum source, such as is commonly available in operating rooms.
The parent applications disclose further embodiments of multi-component, mixed sealant applicators provided with a suction-dispensing cannula, which applicators also employ dual acting suction control valves for enhanced suction control and which are able to employ suction for retrograde clearing of sealant clots from the mixed sealant pathway.
A blown air or gas stream also has utility in the surgical arena and suitable sources of pressurized gas are commonly available, flow control difficulties, the risk of air embolisms and the specialized utility of an air stream as a treatment fluid at a surgical site, raise considerable difficulties in providing applicators and methods for dispensing an air or gas stream which can safely be used in delicate surgical procedures.
For example, it may be difficult to provide a well-directed, gentle flow of air, suitable for surgical application, from the customarily available compressed air sources, and because the need for such a flow may be occasional, or low priority, it may be difficult to justify the expense and inconvenience of a suitably controlled blower as a single-purpose device.
Accordingly, there is a need for a controlled blower and blowing method suitable for applying a gas stream to a surgical site.
To solve this problem the invention provides a controlled blower and blowing method suitable for applying a gas stream to a surgical site which comprises: a blower body connectable with a pressurized gas source; a gas output cannula for directing a dimensionally controlled flow of a suitable treatment gas, for example sterilized air, to a user-selected area of the surgical site; and a user-operable control valve operable to provide a surgically desirable gas flow from the cannula.
In a preferred embodiment the control valve is a dual-acting control valve which can simultaneously enlarge a gas supply throat from the source and diminish a venting throat to provide a desired output gas flow control, particularly at low pressures and flow rates.
Preferably also the blower is a lightweight, hand-held easily manipulated device which is equipped to provide an additional or alternative fluid or fluids at the work site, for example suction, irrigation or a tissue sealant fluid. Such multiple fluid flows can be selectively dispensed by operation of a simple, manually actuated selector, switch or valve on the blower.
In one preferred embodiment, both suction and gas flow are available simultaneously, being dispensed from separate cannulas, with the gas dispensing cannula preferably having a dispensing tip retracted distally behind that of the suction cannula, whereby gas can be circulated from the gas-dispensing cannula, to the work surface and withdrawn from same by the suction cannula.
In another embodiment, suction, and gas flow are selected to be dispersed from the same cannula through a manually actuated selection valve while an irrigation fluid is available simultaneously from the other cannula.
Other embodiments are directed to: gas flow and tissue sealant being dispersed simultaneously or separately from separate cannulas; suction, tissue sealant and gas flow being dispersed simultaneously or separately from separate or several cannulas; and suction, tissue sealant, gas flow and irrigation fluids being dispersed simultaneously or separately from several cannulas.
Preferably, although not necessarily, the sealant is a biological sealant, for example a tissue adhesive, and the area of application is a biological tissue subject to surgery. The sealant components can comprise a first, structural component capable of gelling, and preferably of solidification and a second, activation component which activates such gelling and, optionally, solidification. More preferably, the sealant is a tissue sealant and the first component comprises fibrinogen and the second component comprises, or can generate a fibrinogen activator, especially thrombin or an equivalent thereof.
The invention also includes an applicator and method that provides the user with convenient and ergonomic access to an efficient means for providing suction, blowing and or irrigation in addition to or without simultaneously being able to apply mixed sealant components in accordance with the prior applications provides an novel and unique way of advancing this emerging field while also addressing traditional problems encountered in this and related fields.
The invention includes, but is not limited to, a novel surgical method of applying sealant to unexposed or internal biological surfaces, e.g. human or animal anatomical surfaces, that are accessible to a remote applicators, such as the ones disclosed in aforementioned patent applications. The use of a remote mixing chamber, which receives a flow of multiple sealant components and mixes the sealant components at the distal end of the applicator, allows the distal end of the applicator to apply a mixed sealant a work site.
In addition to the application of sealant(s), the present invention is also directed to an apparatus an method which includes manipulation of a single device to provide one or more of the following; suction, blowing and/or irrigation, in addition to, or without, simultaneously being able to apply mixed sealant components.